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DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc. Recalls

All product recalls associated with DePuy Orthopaedics, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 77 recalls

DePuy Orthopaedics, Inc.: Charnley PN Retract & Handle, REF 962004000, Non-Sterile-...

The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.

Class IIModerate

FDAAug 27, 2014Nationwide• DePuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retai...

There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.

FDAMay 7, 2009Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: DePuy DNP Anatomic Fracture Repair System, Locking Screw ...

The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.

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FDADec 23, 2008Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD,...

Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

FDAJul 10, 2008Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy LCS Knee - Orthopedic knee implant. Meniscal beari...

Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of insert.

FDAMay 6, 2008Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy TK2 Compression Hip Screw trauma plate, Standard Ba...

Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.

FDAOct 30, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System Stabilized Tibial Insert (STA...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System All Polyethylene Curved Tibia...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, ...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5m...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E RP Knee System Rotating Platform Curved T...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDASep 27, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog...

Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

FDAJul 13, 2007Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy Preservation Uni-Compartmental Knee Fixed Tibial T...

Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.

FDANov 15, 2006Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 3...

Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

FDASep 14, 2006Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy brand Acclaim Elbow linked ulnar bearing, sterile; ...

The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

FDANov 8, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy brand LCS Complete metal backed patella, porocoat, ...

There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.

FDAJun 7, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy Preservation Uni Knee All Poly Tibial; polyethylene...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System, stabilized all-polyethylene t...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.